Siklos

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

hydroxycarbamide

Available from:

Theravia

ATC code:

L01XX05

INN (International Name):

hydroxycarbamide

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Anemia, Sickle Cell

Therapeutic indications:

Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.

Product summary:

Revision: 24

Authorization status:

Authorised

Authorization date:

2007-06-29

Patient Information leaflet

25
B. PACKAGE LEAFLET
_ _
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIKLOS 100 MG FILM-COATED TABLET
SIKLOS 1 000 MG FILM-COATED TABLET
hydroxycarbamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Siklos is and what it is used for
2.
What you need to know before you take Siklos
3.
How to take Siklos
4.
Possible side effects
5
How to store Siklos
6.
Contents of the pack and other information
1.
WHAT SIKLOS IS AND WHAT IT IS USED FOR
Siklos is used to prevent painful crises, including sudden chest pain,
caused by sickle cell disease, in
adults, adolescents and children older than 2 years.
Sickle cell disease is an inherited blood disorder that affects the
disc shaped red cells of the blood.
Some cells become abnormal, rigid and take a crescent or sickle shape
which leads to anemia.
The sickle cells also get stuck in blood vessels, blocking blood flow.
This can cause acute pain crises
and organ damage.
For severe painful crises, most patients require hospitalisation.
Siklos will decrease the number of
painful crises as well as the need for hospitalisation linked with the
disease.
The active substance of Siklos, hydroxycarbamide, is a substance which
inhibits growth and
proliferation of some cells, such as blood cells. These effects lead
to a reduction of circulating red,
white and coagulation blood cells (myelosuppressive effect). In sickle
cell disease, hydroxycarbamide
helps also to prevent red blood cells from taking abnormal shape.
2.
WHAT YOU NEED TO KNOW BEFORE YOU

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Siklos 100 mg film-coated tablet.
Siklos 1 000 mg film-coated tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Siklos 100 mg film-coated tablet
Each film-coated tablet contains 100 mg of hydroxycarbamide.
Siklos 1 000 mg film-coated tablet
Each film-coated tablet contains 1 000 mg of hydroxycarbamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Siklos 100 mg film-coated tablet
Off-white oblong-shaped, film-coated tablet with half-scoring on both
sides.
The tablet can be divided into two equal parts. Each half of tablet is
embossed “H” on one side.
Siklos 1 000 mg film-coated tablet
Off-white, capsule-shaped, film-coated tablet with triple scoring on
both sides.
The tablet can be divided into four equal parts. Each quarter of
tablet is embossed “T” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Siklos is indicated for the prevention of recurrent painful
vaso-occlusive crises including acute chest
syndrome in adults, adolescents and children older than 2 years
suffering from symptomatic sickle cell
syndrome (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Siklos should be initiated by a physician experienced
in the management of patients
with sickle cell syndrome.
Posology
_In adults, adolescents and children older than 2 years _
The posology should be based on the patient’s body weight (b.w.).
The starting dose of hydroxycarbamide is 15 mg/kg b.w. and the usual
dose is between 15 and
30 mg/kg b.w./day.
As long as the patient responds to therapy either clinically or
haematologically (e.g. increase in
haemoglobin F (HbF), Mean Corpuscular Volume (MCV), decrease in
neutrophil count), the dose of
Siklos should be maintained.
In case of non-response (re-occurrence of crises or lack of reduction
in crisis rate), the daily dose may
be increased by steps of 2.5 to 5 mg/kg b.w./day using the most
appropriate strength.
Under ex